Nonsurgical intraurethral bladder control device

ABSTRACT

An improved self contained automatic bladder control device includes a valve assembly mount for releasibly receiving a valve assembly. The preferably cylindrical mount has a textured outer surface designed to interact with urethral tissue. Thus the mount can be placed nonsurgically into a urethra and in time it will be held against movement by the tissue interaction with the textured outer surface, yet the mount will still be removable without surgery. Two embodiments of valve assemblies are disclosed, each of which provides a sphincter-like operation of the bladder control apparatus. A first embodiment is designed to use Bernoulli&#39;s law to hold open the valve apparatus after a short period of muscle contraction. The second embodiment is designed to use the fact that the force generated by hydrostatic pressure is directly related to the area on which it impinges, to accomplish the desired valve holding period.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention generally relates to the field of medical devicesand more particularly to bladder control devices, and still moreparticularly to an intraurethral bladder control apparatus commonlyreferred to as an artificial sphincter.

2. Description of the Prior Art

The use of various sphincter and bladder control devices is wide spreadin the field of the present invention. The use of intraurethral valvingapparatus is also well known in the art, as evidenced by, for example,U.S. Pat. Nos. 4,553,533; 4,679,546; 4,969,474; and 5,123,428. Ingeneral terms, it is the goal of the prior art and the present inventionto provide a valving system for a patient's bladder, which system isplaced directly in the urethra and adjacent the bladder. The valvingsystem is ideally turned on by the patient and turned off when thebladder has ,been sufficiently emptied.

Some of the problems and disadvantages found in the prior art include:the need for surgical implantation and removal of the device in theurethra; the susceptibility of the device to leakage or to undesiredvalve openings; the failure of the valve device to stay open long enoughto provide complete emptying of the bladder; and in some prior artdevices the need for an additional external product, such as a magnet,to actuate the valve device.

SUMMARY OF THE INVENTION

The apparatus and method of this invention overcomes these potentialdisadvantages by providing an improved intraurethral bladder controlapparatus which includes a valve assembly, and a valve assembly mountfor releasibly holding the assembly and adapted to be nonsurgicallyplaced and releasibly held in the urethra of a patient. The mount isprovided with a textured outer surface to which urethral tissue willconform to hold the mount at a selected position therein. The valveassembly cooperates with apparatus in an inner chamber of the mount forreleasable installation of the assembly. The mount is preferablygenerally cylindrical in shape with a generally cylindrical innerchamber or lumen where valve assembly holding apparatus is deployed.

Each of the preferred embodiments of the valve assembly has adjustmentapparatus operable whether the assembly is in the valve assembly mountor not, for positioning the assembly and for setting desired values ofthe opening and closing the valve, and for a fail-safe mode which is afeature of each preferred embodiment.

Each preferred embodiment of the present invention also includesapparatus for assuring that once opened by the patient's own abdominalmuscle contraction, the valve stays open for a sufficient time to emptythe bladder, and then closes without further action by the patient. Afirst preferred embodiment includes a design to utilize Bernoulli'sprinciple to provide a negative pressure that holds the valve openduring fluid flow, and a second preferred embodiment is designed toutilize a valve area enlargement during fluid flow to keep the valveopen.

BRIEF DESCRIPTION OF THE DRAWINGS

The above described as well as other objects and many of the attendantadvantages of the present invention will be readily appreciated as theybecome better understood by reference to the following detaileddescription when considered in connection with the accompanyingdrawings, in which like reference numerals designate like partsthroughout all figures:

FIG. 1 is a partial sectional view of a first embodiment of theintraurethral bladder Control apparatus of this invention with the valveclosed;

FIG. 2 is a cross-sectional view of FIG. 1 taken along the line 1--1;

FIG. 2 is another cross-sectional view of FIG. 1 taken along the line2--2;

FIG. 4 is yet another cross-sectional view of FIG. 1 taken along theline 3--3;

FIG. 5 is a partial sectional view of the embodiment of FIG. 1 with thevalve open; FIG. 6 is a cross-sectional view of a second embodiment ofthe apparatus of this invention with the valve closed;

FIG. 7 is another cross-sectional view of the embodiment of FIG. 6 withthe valve open;

FIG. 8 is a plan view of the valve assembly mount of this invention; and

FIG. 9 is a plan view of a valve assembly of this invention.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

Referring first to FIG. 8 there is shown a valve assembly mount 2 in thepreferred form of a cylinder having a textured outer surface 16 designedto interact with urethral tissues such that mount 2 may be nonsurgicallyand releasibly positioned in a patient's urethra. Mount 2 includes avalve orifice indicated at 11 and adapted to be positioned adjacent thepatient's bladder exit, and an assembly orifice indicated at 19 adaptedto receive a valve assembly for internal mounting. As disclosed and morefully described in other figures of the drawings, the interior of mount2 includes connection apparatus for releasibly and adjustably mounting avalve assembly. In practice, mount 2 is positioned in the patient'surethra first, left for a period of time to enable the urethra tissue toconform to the textured outer surface 16 of mount 2 to hold mount 2securely in place, and then a valve assembly is mounted in mount 2.

In FIG. 9 there is shown a valve block 33 adapted to releasibly receivea valve apparatus in a manner fully described below with reference toother figures of the drawings. Block 33 is shown as preferably having athreaded outer surface designed to match a threaded inner surface (notshown in FIG. 8) of mount 2. Block 33 also has a valve orifice indicatedat 21 for alignment adjacent to orifice 11 of mount 2, and an apparatusreceiving orifice indicated at 29 for insertion of a valve apparatus.

As can be seen in FIG. 9, when a valve apparatus is in place withinblock 33, an adjustment device 10 having lock notches 9 will beavailable outside block 33. By using an appropriate adjustment tool (notshown) to lock into notches 9, device 10 may be rotated to make aplurality of adjustments more fully described below with reference toother figures of the drawings.

Referring now to FIG. 1 there is shown a first embodiment of the bladdercontrol apparatus 1 of this invention, including cylindrical valveassembly mount 2 having textured outer surface 16 and a valve assembly20 which is threaded into mount 2 by means of a connection thread 15.Valve assembly 20 includes a valve block 13, a valve 17, a valve orifice11, a valve ring 7 having a valve area 12, a coiled spring or otherbiasing apparatus 4, a spacer 6, a stationary ring 3, a fluid passage 8,a bias adjustment apparatus 5, a thread 14 joining bias adjustmentapparatus 5 to block 13, and adjustment device 10 having locking notches9.

The cross-sectional views of FIGS. 2, 3 and 4, respectively taken alongthe lines 1--1 , 2--2 and 3--3, more clearly depict the inner structureof device 1 of FIG. 1, clarifying the positioning and formations ofvalve 17, spring coil biasing device 4, bias adjustment means 5 withthread 14, fluid passages 8, stationary ring 3 and spacers 6.

In FIG. 1 valve 17 is in the closed position in orifice 11, thuspreventing the flow of urine fluids from the bladder. With reference toFIG. 5, valve 17 is shown in the open position, removed from orifice 11,and a plurality of lines with arrows depict the fluid flow path throughvalve block 13.

In practice, valve assembly mount 2 is first inserted into a urethra andallowed to, stay for a period of time (usually a few weeks) sufficientfor the urethral tissue to conform to the textured outer surface 16 tothus essentially immobilize mount 2. After mount 2 is firmly held by thetissue, a valve assembly such as assembly 20 of FIG. 1 is inserted intothe internal chamber or lumen of mount 2 where it is connected andadjusted.

Referring now to the first preferred embodiment of FIGS. 1-5 whichutilize Bernoulli's principle to retain the valve in an open position,assume that assembly 20 has been mounted in the lumen of assembly mount2 which has been immobilized in the patient's urethra in the mannerdescribed above. Block 13 is then adjusted within mount 2 such thatorifice 11 passes through orifice 21, as shown in FIG. 8, to align withthe output from the patient's bladder (not shown). As the bladder fillswith urine, the resulting growth in the urine column exerts greaterpressure on valve 17 through orifice ll and at the same time theresulting growth in volume within the bladder stimulates the patient'sneed to void. To initiate the voiding process the patient need onlycontract the muscles of the lower abdominal cavity for a short period ofa few seconds. This short period of contraction will increase thepressure on valve 17 long enough for it to move against the bias ofspring 4 and thus begin the flow of urine through valve assembly 20along the path shown by the arrows in FIG. 5.

As the urine flows in the path shown, valve 17 moves toward valve stopor rest 6. Rest 6 is a vertical element extending radially forseparating the lower surface of valve ring 7 from stationary ring 3. Theurine then flows around the edge of valve ring 7 and between the lowersurface of ring 7 and stationary ring 3, such that a negative pressureis induced according to Bernoulli's principle between these twosurfaces. This negative force overcomes the tension of spring 4 andholds ring 7 down against stop 6, thus holding valve 17 open, as long asa sufficient flow of urine is present. When the flow decreases below asufficient amount, the negative force is decreased until the bias fromspring 4 can again close valve 17 in orifice 11 to cut off the flowentirely.

The result of the actions as described in the preceding paragraph causesthe desired holding pattern for the artificial sphincter device of thisinvention. That is, once valve assembly 20 has been opened by musclecontraction to allow fluid flow through block 13, the application ofBernoulli's law will automatically prevent closure of valve 17 withoutfurther muscle contraction until the bladder has emptied enough tosignificantly reduce the urine flow; and then the valve assembly willautomatically close without further muscle effort. The patient's need tovoid will have been met by a simple, short initial contraction of themuscles of the lower abdominal cavity.

The force with which valve 17 is held closed or seated in orifice 11 isdetermined by the tension from spring 4, which may be any form of biasdevice. This tension or bias is adjusted by bias adjustment apparatus 5,best seen in FIGS. 1 and 3. To set the desired tension of coil 4, anadjustment tool (not shown) is passed through the urethra to grasp andlock into notches 9 of adjustment device 10, Device 10 is thenselectively rotated which rotates valve 17 and bias adjustment means 5.The rotation of means 5 causes it to move up or down thread 14 toincrease or decrease the tension of spring 4.

The rotation of valve 17 in the direction of reduced bias from coil 4will eventually disable bladder control device 1 by removing valve 17from is seat in orifice 11 to allow a free flow of fluid through block13. Further rotation after reaching the point of free flow will causerotation of block 13 to first change its positioning within mount 2 andeventually to cause it to disengage from mount 2 entirely. Replacementof block 13 into mount 2 is accomplished by simply reversing thedirection of rotation of device 10.

The above description of the structure and operation of the preferredembodiment of FIGS. 1-3 which utilizes Bernoulli's law is applicable topatients who have a sufficiently rapid rate and volume of urine flow.These values can be clinically determined. If it is found that thepatient does not meet the requirements for the use of the abovedescribed embodiment, the second preferred embodiment of this inventionas described in FIGS. 6-7 can be used.

FIG. 6 again shows a valve assembly mount 2 in which a valve block 43 isremovably positioned through use of threads 15. A valve 47 abuts againstan orifice 41 and is maintained in the closed position by a coil springor other bias device 4. In this embodiment valve 47 has a valve ring 27with a valve surface area 42 significantly greater than the area oforifice 41. Coil 4 abuts against bias adjustment device 25 which isconnected to block 43 via thread 44. Valve 47 is connected to adjustmentdevice 10 which again carries locking notches 9. Fluid passages 28 areprovided to pass urine through block 43 along a desired path.

In FIG. 6 valve 47 is shown as biased against orifice 43, thus closingvalve block 43 to prevent urine flow. Referring now to FIG. 7 valve 17is shown in the open position and the flow of urine through block 43 isdepicted by the arrows. In operation, mount 2 will have first beensecured in the patient's urethra in the nonsurgical, removable mannerdescribed above with regard to FIGS. 1-5. Thus the urethral tissue willhave conformed to surface 16 to hold mount 2 in place. Block 43 willthen be treaded into mount 2 to place orifice 41 in the urethra adjacentto the patient's bladder. As the bladder fills the urine column willplace increased pressure on valve 47 through orifice 41, as well ascausing a need to void in the patient. To initiate operation of thedevice of this embodiment of the present invention the patient againneed only contract the muscles of the lower abdominal cavity for a fewseconds. This short period of contraction will cause sufficient pressurefor valve 47 to open against the tension of coil spring 4.

As soon as valve 47 opens, the urine flow through orifice 41 willimpinge on the full surface area 42 of valve ring 27, and since thisarea is greater than the area of orifice 41, valve 47 will remain openeven after the contractions are released, until the urine column hasbeen reduced to an acceptable small amount. The basis of this embodimentis the known fact that force generated by hydrostatic pressure isdirectly related to the area of impingement, that is,Force=Pressure×Area. Thus valve ring 27 and orifice 41 can be designedto follow the fact that if valve area increases n times, the pressuremay decrease n times, and the force exerted on the valve remain thesame. By making ring 27 of sufficient surface area 42 relative to thearea seen through orifice 41, valve 47 will be held open after musclecontraction ceases even in a patient with a relatively low flow ratethrough the urethra.

Valve 47 will remain open until the fluid pressure has dropped such thateven the increased area is not enough to afford a multiple that willovercome the bias of coil 4, and then valve 47 will automatically bebiased closed and remain closed until the bladder fills and the patientcreates another contraction. Thus, as in the case of the firstembodiment described above, this embodiment of the invention will alsooperate in a manner closely resembling the action of a normal sphinctermuscle.

In both embodiments described above there are fail-safe measuresdesigned into the bladder control device. By proper selection of thetension on the respective of valves 17 or 47 caused by bias apparatus 4,the valves can be made to open without muscle contraction as thepressure passes a certain level in the bladder. This can avoid seriousproblems caused by the increased bladder pressure should the patient notrecognize the need to void or be unconscious, or the like. Further,again by proper adjustment of the bias spring, accidental turn-on of thebladder control device due to unexpected contractions, for example froma sneeze or cough. In general, if a proper spring tension is selectedand the bladder is not overly full, valves 17 and 47 will remain seateduntil a contraction force of sufficient strength has been present formore than an instantaneous period of time, such as the time of a cough.This need for a short but sustained period of contraction prevents thedevice from entering its "automatic open" phase after an unexpectedabrupt contraction.

Having thus described the preferred embodiments of the presentinvention, those of skill in the art will readily appreciate the otheruseful embodiments within the scope of the claims hereto attached.

I claim:
 1. In an intraurethral bladder control apparatus including avalve assembly for controlling the flow of urine and a valve assemblymount for holding the valve assembly within a urethra, the improvedvalve assembly mount comprising:means including a textured outer wall onthe mount for interacting with urethral tissue to hold said bladdercontrol apparatus within the urethra and provide nonsurgicalimplantation and removal of the mount in the urethra the valve assemblyincluding means for creating a holding force according to Bernoulli'sprinciple responsive to a flow of fluid, and means responsive to theholding force to hold the valve assembly open.
 2. The apparatus of claim1 in which the valve assembly mount includes an inner chamber havingvalve assembly holding means for releasibly holding the valve assemblyin the chamber.
 3. The apparatus of claim 2 in which the valve assemblyincludes adjustment control means for setting the pressures at which thevalve assembly will open and close.
 4. The apparatus of claim 3including means for operating the adjustment control means for a pointexternal to the urethra.
 5. The apparatus of claim 2 in which the valveassembly includes: means responsive to an opening of the valve forincreasing the area of fluid flow impingement; and means responsive topressure from fluid flow impingement to hold the valve assembly open. 6.The apparatus of claim 1 or 5 in which the valve assembly includesadjustment control means for setting the pressures at which the valveassembly will open and close.
 7. Bladder control apparatus comprising:a.a valve assembly mount adapted for intraurethral placement; b. meansincluding a textured outer surface on the mount for holding said bladdercontrol apparatus in contact with urethral tissue; c. a chamber in theamount; d. connection means in the chamber for receiving and releasiblyholding a valve assembly; e. a valve assembly adapted to be connected tothe connection means; f. a moveable valve in the valve assembly foropening and closing the assembly to fluid flow; g. bias means forbiasing the valve closed; h. pressure means for holding the valve openin the presence of a fluid flow of a predetermined level; i. a firstvalve ring mounted on the moveable valve and within a fluid flow pathwithin the valve assembly; j. a second valve ring mounted on theconnection means and within the fluid flow path; k. a spacer mounted inthe valve assembly for maintaining a minimum spaced between the firstand second rings; and l. the first and second rings cooperating in thepresence of fluid flow of a predetermined level to induce a negativeforce according to Bernoulli's principle for holding the moveable valveopen.
 8. The apparatus of claim 7 in which the pressure sensing meanscomprises:a. a valve ring mounted on the moveable valve and having apredetermined surface area; b. means for exposing a first portion of thesurface area to hydrostatic pressure when the moveable valve is closed;and c. means for exposing a second and larger portion of the surfacearea to the hydrostatic pressure when the moveable valve is open forholding the valve open during fluid flow at a predetermined level. 9.The apparatus of claims 7 or 8 in which the valve assembly includesadjustment control means for adjusting the bias of the bias controlmeans to set the pressures at which the valve assembly will open andclose.
 10. the apparatus of claim 9 including means for operating theadjustment control means from a point external to the body.
 11. Theapparatus of claims 7 or 8 including fail-safe means for preventing themovement of the moveable valve due to abrupt changes in hydrostaticpressure.
 12. The apparatus of claim 7 including fail-safe means forpreventing the opening of the valve assembly due to abrupt changes inhydrostatic pressure.
 13. Intraurethral bladder control apparatuscomprising:a. a housing having an outer surface and an inner chamber; b.a valve assembly having an input orifice and an output orifice, and afluid flow path between the input and output orifices; c. a moveablevalve mounted in the valve assembly and moveable between a closedlocation adjacent the input orifice and an open position spaced from theinput orifice; d. valve closing means for normally holding the valve inthe closed position and responsive to a predetermined pressure to allowmovement of the valve to the open position; and e. valve control meansmounted in the valve assembly fluid flow path and responsive to the flowof fluid to hold the valve in the open position when the fluid flow rateis above a predetermined rate.
 14. The apparatus of claim 13 in whichthe valve control means comprises: means for inducing a negativepressure under Bernoulli's principle in the presence of a fluid flow.15. The apparatus of claim 13 in which the valve control meanscomprises: means having a predetermined surface area and means forincreasing the portion of the surface area within the fluid flow pathwhen the valve is in the open position, to hold the valve in the openposition which the fluid pressure is above a predetermined level. 16.The apparatus of claims 13, 14 or 15 in which the valve closing meanscomprises: a spring and spring tension adjustment means.
 17. Theapparatus of claims 13, 14 or 15 including safety means for preventingmovement of the valve to the open position due to momentary changes inbladder pressure.
 18. The apparatus of claims 13, 14 or 15 in which:said housing outer surface is textured for interacting with urethraltissue to releasibly hold said housing in the urethra.
 19. In bladdercontrol apparatus adapted to be placed in a urethra and including avalve block having a valve with open and closed positions and a fluidflow path through the valve block, the method of controlling fluid flowcomprising the steps of:a. normally biasing the valve in the closedposition; b. moving the valve to the open position when the hydrostaticpressure in the urethra exceeds a predetermined level; c. inducing anegative pressure from means in the fluid flow path according toBernoulli's principle; d. holding the valve in the open position withthe negative pressure; and e. moving the valve to the closed positionwhen the induced negative pressure falls below the normal biasingpressure.
 20. In bladder control apparatus adapted to be placed in aurethra and including a valve block having a valve with open and closedpositions and a fluid flow path through the valve block, the method ofcontrolling fluid flow comprising the steps of:a. normally biasing thevalve in the closed position; b. moving the valve to the open positionwhen the hydrostatic pressure in the urethra exceeds a predeterminedlevel; c. increasing the surface area of impingement of the fluid flowon means in the flow path to create a valve holding pressure; d. holdingthe valve in the open position with the valve holding pressure; and e.moving the valve to the closed position when the valve holding pressurefalls below the normal biasing pressure.
 21. The method of claims 19 or20 including the step of: preventing movement of the normally closedvalve due to an abrupt change in the urethral hydrostatic pressure. 22.An intraurethral bladder control apparatus comprising:a. a housing forremovable attachment within a urethra; and b. valve means coupled tosaid housing for controlling fluid flow through said urethra, uponexposure to a predetermined pressure said valve means opening toinitiate fluid flow, said valve means remaining open under the influenceof a holding force according to Bernoulli's principle and said fluidflow continuing through said urethra at a pressure less than saidpredetermined pressure.
 23. An intraurethral bladder control apparatusaccording to claim 22 further comprising means coupled to said housingfor resetting said initiating and continuing means to a state whichprevents further fluid flow through said urethra until renewed exposureto said predetermined pressure.